In a groundbreaking new study THC-free medical is being tested in autistic children for the first time.
The world’s first study of full extract cannabis, containing little to no THC, in children diagnosed with Autism Spectrum Disorder (ASD) has been launched.
The Phase I/II open label clinical study, announced last week, by Australian company Neurotech, will assess the safety and efficacy of medical cannabis in 20 autistic children aged between five and 17-years-old.
Over 16 weeks, children will be given a daily dose of the firm’s NTI/Dolce FEN 164 strain and researchers will measure outcomes relating to behaviour, agitation and irritability and overall quality of life.
This is the first time full-spectrum medicinal cannabis strains, containing less than 0.3 percent THC, will be assessed in ASD.
It follows the successful completion of a series of in vitro studies that demonstrated that the strains with the newly-discovered rarer cannabinoids CBDP and CBDB, have unique properties that extend beyond CBD alone.
As well as reducing inflammation within the brain cells , the strains were found to increase neuro-regulatory and neuro-modulatory activities, with no negative effects on cell health.
In all tests, CBDP and CBDB were found to between 30 and 80 percent more potency than CBD alone.
The study is being conducted under the supervision of Professor Michael Fahey, head of Paediatric Neurology Monash Children’s Hospital, who commented: “It is exciting to undertake a properly planned and executed study on a novel CBD product. Many other studies do not have the rigor to ensure that the results are translatable to evidence based clinical treatments.”
Neurotech is a medical device and solutions company committed to improving the life of people with neurological conditions.
The company’s flagship Mente Autism device will also be assessed in combination with the medicinal cannabis strains.
“This is a very exciting and novel approach to the treatment of ASD for which there is the need for safe, effective therapies with no side effects that can improve a patient’s quality of life,” said chairman, Brian Leedman.
“Medicinal cannabis has the potential to provide this treatment, but only NTI/Dolce naturally derived strains offer full-spectrum CBDs with little to no THC, an important consideration when treating children.”